# FDA 483 - Conformis, Inc. - September 07, 2018

Source: https://www.keypedia.com/records/483/conformis-inc/0514b5ab-ceff-4ca9-85f9-03c06e4aad36

> FDA 483 for Conformis, Inc. on September 07, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Conformis, Inc.
- Inspection Date: 2018-09-07
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Conformis, Inc., a medical device manufacturer in Billerica, MA, revealed significant deficiencies in its quality system. The firm failed to adequately establish and follow procedures for design changes, process validation, corrective and preventive actions, vendor controls, and complaint handling. These issues indicate a systemic breakdown in ensuring the quality and safety of their Knee Replacement and Repair Implant Systems.

## Related Documents

- [483 - 2018-09-07](https://www.keypedia.com/records/483/conformis-inc/c23d4393-b80f-42b2-b0e4-ce057d2e7844)
- [483 - 2019-09-20](https://www.keypedia.com/records/483/conformis-inc/7529268a-48d0-4b0b-bc1b-765d620f2d02)
- [483 - 2023-03-09](https://www.keypedia.com/records/483/conformis-inc/93596f10-0732-423a-883c-86dd4c338fe5)

## Related Officers

- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)

Company: https://www.keypedia.com/companies/conformis-inc/4d049221-15de-4b53-addf-68ea7fed8cbc

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94